Events

Recall of Device Recall InterGuard 5.5mm Econo Refill

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ultradent Products, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72814
  • Event Risk Class
    Class 2
  • Event Number
    Z-0583-2016
  • Event Initiated Date
    2015-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142285
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Instruments, dental hand - Product Code DZN
  • Reason
    Ultradent is recalling interguard 5.5mm econo refill, lot#s bc2gn and bc4l7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.
  • Action
    Ultradent Products sent an Urgent Medical Device Correction letter dated December 21, 2015 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard remaining inventory. Replacement product will be sent to each of the identified customers upon completion. For questions regarding the recall call 801-553-4366 or 801-553-4220.

Device

Device Recall InterGuard 5.5mm Econo Refill
  • Model / Serial
    lot#s BC2GN and BC4L7
  • Product Classification
    Dental Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Austria, Canada, Colombia, Denmark, France, Germany, Great Britain, Iceland, and Portugal.
  • Product Description
    InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 || Product Usage: || InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion.
  • Manufacturer
    Ultradent Products, Inc.

Manufacturer

Ultradent Products, Inc.
  • Manufacturer Address
    Ultradent Products, Inc., 505 W 10200 S, South Jordan UT 84095-3935
  • Manufacturer Parent Company (2017)
    Ultradent Products Inc
  • Source
    USFDA